Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
147529–147552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1985
DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR
K853336 · JSH
Hardy Media
Microbiology · 20d
Cleared Aug 29, 1985
6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG
K853342 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W
K853343 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT
K853344 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
SYNCHRONER TM (PROPOSED TRADENAME)
K853350 · CCQ
Fisons Corp.
Anesthesiology · 17d
Cleared Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · GGP
American Dade
Hematology · 10d
Cleared Aug 29, 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · GGP
American Dade
Hematology · 10d
Cleared Aug 29, 1985
BBL CAMPY POUCH
K853534 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 6d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
K852836 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
K852837 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS MES TENS
K852838 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · DGC
Diagnostic Products Corp.
Immunology · 50d
Cleared Aug 28, 1985
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
K853048 · DER
Photec Diagnostics, Inc.
Immunology · 40d
Cleared Aug 28, 1985
H-H VENTRICULAR CATHETERS & RESERVOIRS
K853361 · JXG
Holter-Hausner Intl.
Neurology · 16d
Cleared Aug 28, 1985
HILLCREST AMEBIASIS IHA TEST
K853448 · KHW
Hillcrest Biologicals
Microbiology · 12d
Cleared Aug 28, 1985
LX EMBEDDING CENTER
K853463
Innovative Medical Systems, Inc.
Pathology · 9d
Cleared Aug 28, 1985
STAPH KIT
K853488 · JSI
Culture Kits, Inc.
Microbiology · 8d
Cleared Aug 28, 1985
PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
K853497 · IFP
Surgipath Medical Industries, Inc.
Pathology · 8d
Cleared Aug 28, 1985
ORTHO VIRAL TRANSPORT
K853500 · JSM
Ortho Diagnostic Systems, Inc.
Microbiology · 8d
Cleared Aug 27, 1985
O.M.S. UV-COLOURS
K851410 · HQG
Optical Moulding Systems
Ophthalmic · 140d
Cleared Aug 27, 1985
URI-SURE
K852619 · KNX
Ashai Co. , Ltd.
Gastroenterology & Urology · 68d
Cleared Aug 27, 1985
LAURIER SAFETY LONG SANITORY NAPKIN
K852924 · HHD
Kao Corp.
Obstetrics & Gynecology · 49d
Cleared Aug 27, 1985
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · FCW
Welch Allyn, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 27, 1985
ENTERAL FEEDING CONTAINER
K852966 · KNT
Empire Industries, Inc.
Gastroenterology & Urology · 46d